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Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)

NCT04357808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-11

No results posted yet for this study

Summary

The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.

Conditions

Interventions

DRUG

Sarilumab

Single dose treatment with sarilumab 2 x 200 mg subcutaneously

OTHER

Standar of care

Usual clinical care

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

    collaborator OTHER

  • Maria del Rosario Garcia de Vicuña Pinedo

    lead OTHER

Principal Investigators

  • Rosario Garcia de Vicuña, MD PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2020-11-30
Completion
2020-12-04

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357808 on ClinicalTrials.gov